ARTHREX FRACTURE PLATES

K123241 · Arthrex, Inc. · HRS · Apr 5, 2013 · Orthopedic

Device Facts

• Record ID: K123241
• Device Name: ARTHREX FRACTURE PLATES
• Applicant: Arthrex, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Fracture Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, and fibula. The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates. The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Device Story

Arthrex Fracture Plates and Low Profile Screws; family of titanium and stainless steel plates and screws for internal bone fixation. Plates range 50-244 mm; screws range 2.0-6.7 mm diameter. Used by surgeons in clinical settings for stabilization of bone fractures, fusions, osteotomies, and non-unions. Mechanical fixation provided by plate-screw system or stand-alone screws; restores structural integrity of bone; facilitates healing. Output is physical stabilization of bone segments.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated bending, pull-out, and torque strength equivalent to predicate devices.

Technological Characteristics

Materials: Titanium or stainless steel. Form factor: Flat and contoured plates (50-244 mm) and screws (2.0-6.7 mm diameter). Principle: Mechanical bone fixation. No software or electronic components.

Indications for Use

Indicated for internal bone fixation for fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula. Patient population not specified by age or gender.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes One-third Tubular Plates (K011335)
• Acumed Congruent Bone Plate System (K102998)
• Low Profile Screw (K103705)
• Low Profile Screw (K111253)
• Low Profile Screw (K112437)

Submission Summary (Full Text)

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K123241 (Page 1 of 2)

# APR 0 5 2013

# 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | September 12, 2012 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith<br>Manager, Regulatory Affairs<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1720<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Fracture Plates |
| Common Name | Plate, fixation, bone |
| Product Code -Classification | HWC, HTN, HRS |
| Name<br>CFR | 21 CFR 888.8030: Single/multiple component metallic bone<br>fixation appliances and accessories<br>21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener |
| Predicate Device | K011335: Synthes On-third Tubular Plates<br>K102998: Acumed Congruent Bone Plate System<br>K103705 / K111253 / K112437: Low Profile Screw |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to<br>obtain clearance for the Arthrex Fracture Plates and the<br>accompanying screws. |
| Device Description and Intended<br>Use | The Arthrex Fracture Plates are a family of titanium and<br>stainless steel plates and screws. The plates are flat and<br>contoured, ranging from 50 mm to 244 mm in length. The<br>accompanying screws are 2.5mm to 6.7mm in diameter. |
| Intended Use | The Arthrex Fracture Plates are intended to be used for<br>internal bone fixation for bone fractures, fusions, osteotomies<br>and non-unions in the ankle, foot, hand, wrist, clavicle,<br>scapula, olecranon, humerus, radius, ulna, tibia, calcaneus,<br>and fibula.<br>The Arthrex Low Profile Screws (2.0-2.4mm solid) are<br>intended to be used as stand-alone bone screws, or in a<br>plate-screw system for internal bone fixation for bone<br>fractures, fusions, osteotomies and non-unions in the |
| | ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates. |
| | The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. |
| | The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates. |
| | The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. |
| Substantial Equivalence Summary | Fracture Plates are substantially equivalent to the predicate Synthes One-Third Tubular Plates (K011335), Acumed Congruent Bone Plate (K102998), and the cleared Low Profile Screws (K103705, K111253, and K112437) in which the basic features and intended uses are the same. Any differences between the Fracture Plates and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
| | The proposed devices are composed of Titanium or Stainless Steel, which is substantially equivalent to the predicate devices. |
| | The submitted mechanical testing data demonstrated that the bending, pull-out and torque strength of the proposed devices are substantially equivalent to the bending, pull-out and torque strength of the predicate devices. |
| | Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Fracture Plates is substantially equivalent to currently marketed predicate devices. |

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Public Health Service

Letter dated: April 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Arthrex, Incorporated % Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K123241

Trade/Device Name: Arthrex Fracture Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 13, 2013 Received: February 25, 2013

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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#### Page 2 - Ms. Courtnev Smith

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark NMelkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

### Indications for Use

510(k) Number (if known): K123241

Device Name: Arthrex Fracture Plates

Indications For Use:

The Arthrex Fracture Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

Prescription Use _ V __ (Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

AND/OR Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

# Elizabeth L. Frank -S

Division of Orthopedic Devices

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## Indications for Use Form

### Indications for Use

510(k) Number (if known): K123241

Arthrex Low Profile Screws Device Name:

Indications For Use:

The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.

The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.

The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Prescription Use _ V _ AND/OR Over-The-Counter Use ___________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

## Elizabeth | 読版ank -S

Division of Orthopedic Devices